Happy Holidays

We founded Novateur this year with one mission: to provide virtual, world class solutions to biotech, med-tech, and pharmaceutical companies for the purposes of advancing their product development smarter and faster while spending less.

We started the year with one regulatory expert and 5 medical device engineers and ended the year with over 60 highly qualified experts; combined, our experts bring experience with over 85 marketed drugs and devices (several of them blockbusters) and successful filings for over 53 NDA/BLAs and 115 INDs. We cover all drug and device development spectrums.

The team and their experience is global but can be accessed through Novateur at anytime at any place. We started the year working for one client and ended the year with serving multiple clients globally.

Creating an organization in such in a relatively short period of time has not been easy and could not have been possible without everyone’s support. Those receiving this newsletter have played a role in assisting us in creating Novateur and I would like to thank you for all of your contribution and support.

We cannot wait for 2016 and the challenges it will bring us.

2015 was an interesting year for a number of reasons:

1. FDA approved a record 42 drugs in 2015 (vs. 41 approvals in 2014). We expect this trend to continue. According to the IMS, the flurry of drug approvals over the next four years (225, to be exact, and most of them in cancer-related therapeutic spaces) will continue.

2. The biotech index had a significant correction in September and did not recover. Many nano-cap and small-cap biotech companies that had gone public in the IPO frenzy of 2014―2015 have lost significant portion of their valuation and will be struggling to recover to their original IPO pricing. This will provide a great opportunity for a number of M&As.

We believe 2016 will be more competitive to raise money and to find a partner.

Hence more than ever product differentiation and clear development strategy and effective execution matter.

Smart strategies and forward thinking development can set apart winners.

We wish each and every one of you a phenomenal 2016; filled with joy, health and success.